Dermatitis, AtopicPhase 3NCT02182557
WAL 801 CL Dry Syrup in Paediatric Atopic Dermatitis Patients
A Phase 3 study testing WAL 801 CL Dry Syrup and Ketotifen Fumarate Dry Syrup in people with Dermatitis, Atopic, run by Boehringer Ingelheim.
Trial summary
Study to investigate the safety and efficacy of WAL 801 CL Dry Syrup on pruritus associated with paediatric atopic dermatitis in comparison with that of Ketotifen Fumarate Dry Syrup and to confirm the appropriateness of dosage of WAL801 Dry Syrup. Read more about this study
- Who is it for?
- Ages Up to 15 years
- Conditions the study is for
- Dermatitis, Atopic
- What is being tested?
- WAL 801 CL Dry Syrup and Ketotifen Fumarate Dry Syrup
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 162 participants
- Where
- No sites listed yet
- Study dates
- Jun 2001to Jan 2002
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- For inclusion in this study, patients must be pediatric atopic dermatitis patients that meet the following criteria and thus be appropriate for observation of pruritus. Diagnosis of atopic dermatitis was conducted in accordance with the "Definition and Diagnostic Criteria of Atopic Dermatitis" issued by the Japanese Dermatological Association.
- 15 years of age or younger
- Body weight of 14 kg or more
- Outpatients
- One week or longer has passed since the patient started to use an external steroid preparation at "Strong" or lower grade, or stopped using any external steroid preparation, at the time of obtainment of consent from the patient
- Pruritus with "2" or higher grade, immediately before initial administration
Who cannot join
- Use of sustained release adrenocorticotropic hormone (Kenacort® A, Depo-medrol®, etc.), oral preparation of methotrexate, or oral preparation of ciclosporin, within 4 weeks before initial administration of the investigational product
- Oral intake, inhalation and injection of any steroid within 2 weeks before initial administration of the investigational product
- Use of any external steroid preparation at "Very Strong" or higher grade in any sites other than the face or scalp within 2 weeks before initial administration of the investigational product
- Undergoing phototherapy
- Undergoing specific desensitization therapy or modulation therapy
- Past history of contact dermatitis caused by external steroid preparation
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- Possibility of exacerbation by an external steroid preparation of infectious skin disease caused by bacteria, fungi, or virus
- Present and past history of convulsive disorder, such as epilepsy (convulsion threshold values may be lowered by the reference drug, Ketotifen Fumarate)
- Clinically significant hepatic, renal, or cardiac disease or other complications: therefore, judgement that the patient is ineligible for inclusion in this study (Please note that patients must be excluded from the study if the patients fell under Grade 2 or more, in the MHW (Ministry of health and welfare) Adverse Reaction Severity Classification Criteria.)
- Past history of allergy to any drug
- Participation in any other clinical study, or history of participation in any other clinical study within 6 months before the date when the patient gave consent to participate in this study
- Judgement by the Principal Investigator or Investigator that the patient is ineligible for inclusion in this study
About this study
Official title: Phase III Double-Blind Comparative Study of WAL 801 CL Dry Syrup in Paediatric Atopic Dermatitis Patients
Study to investigate the safety and efficacy of WAL 801 CL Dry Syrup on pruritus associated with paediatric atopic dermatitis in comparison with that of Ketotifen Fumarate Dry Syrup and to confirm the appropriateness of dosage of WAL801 Dry Syrup.
- Conditions
- Dermatitis, Atopic
- Being tested
- WAL 801 CL Dry Syrup, Ketotifen Fumarate Dry Syrup, WAL 801 CL Dry Syrup placebo, Ketotifen Fumarate Dry Syrup placebo
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WAL 801 CL Dry SyrupDrug
Ketotifen Fumarate Dry SyrupDrug
WAL 801 CL Dry Syrup placeboDrug
Ketotifen Fumarate Dry Syrup placeboDrug
| Study group | Role | What they receive |
|---|---|---|
| WAL 801 CL Dry Syrup + Placebo | Experimental | Not described Receives: Drug: WAL 801 CL Dry Syrup; Drug: Ketotifen Fumarate Dry Syrup placebo |
| Ketotifen Fumarate Dry Syrup + Placebo | Active comparator | Not described Receives: Drug: Ketotifen Fumarate Dry Syrup; Drug: WAL 801 CL Dry Syrup placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Degree of pruritus
Measured: at week 4
Secondary outcomes (6)
Degree of pruritus
Measured: at week 2
Degree of rash
Measured: at weeks 2 and 4
Pruritus score obtained through the itching questionnaire
Measured: at weeks 2 and 4
Impression on pruritus of the patient or the parent
Measured: at week 4
Occurrence of adverse events
Measured: up to 4 weeks
Number of patients with abnormal changes from baseline in laboratory measurements (hematological tests, blood biochemical tests, and urinalysis)
Measured: Baseline and week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2014 (estimated)
- Study startJun 2001
- Primary completionJan 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dermatitis, AtopicStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 162 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02182557
- Sponsor's protocol ID
- 262.259
- Status last verified
- Jul 2014
- First submitted
- 2 Jul 2014
- Last updated
- 14 Jul 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Double-Blind Comparative Study of WAL 801 CL Dry Syrup in Paediatric Atopic Dermatitis Patients
- ClinicalTrials.gov ID
- NCT02182557
- Acronym / sponsor ID
- 262.259
- Conditions
- Dermatitis, Atopic
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 162 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Jun 2001
- Primary completion
- Jan 2002 (actual)
- First posted
- 8 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study to investigate the safety and efficacy of WAL 801 CL Dry Syrup on pruritus associated with paediatric atopic dermatitis in comparison with that of Ketotifen Fumarate Dry Syrup and to confirm the appropriateness of dosage of WAL801 Dry Syrup.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| WAL 801 CL Dry Syrup + Placebo | Experimental | Drug: WAL 801 CL Dry Syrup, Drug: Ketotifen Fumarate Dry Syrup placebo |
| Ketotifen Fumarate Dry Syrup + Placebo | Active comparator | Drug: Ketotifen Fumarate Dry Syrup, Drug: WAL 801 CL Dry Syrup placebo |
Who may qualify
- Ages
- Up to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- For inclusion in this study, patients must be pediatric atopic dermatitis patients that meet the following criteria and thus be appropriate for observation of pruritus. Diagnosis of atopic dermatitis was conducted in accordance with the "Definition and Diagnostic Criteria of Atopic Dermatitis" issued by the Japanese Dermatological Association.
- 15 years of age or younger
- Body weight of 14 kg or more
- Outpatients
- One week or longer has passed since the patient started to use an external steroid preparation at "Strong" or lower grade, or stopped using any external steroid preparation, at the time of obtainment of consent from the patient
Key exclusion criteria (12 listed)
- Use of sustained release adrenocorticotropic hormone (Kenacort® A, Depo-medrol®, etc.), oral preparation of methotrexate, or oral preparation of ciclosporin, within 4 weeks before initial administration of the investigational product
- Oral intake, inhalation and injection of any steroid within 2 weeks before initial administration of the investigational product
- Use of any external steroid preparation at "Very Strong" or higher grade in any sites other than the face or scalp within 2 weeks before initial administration of the investigational product
- Undergoing phototherapy
- Undergoing specific desensitization therapy or modulation therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WAL 801 CL Dry Syrup | Drug | WAL 801 CL Dry Syrup + Placebo |
| Ketotifen Fumarate Dry Syrup | Drug | Ketotifen Fumarate Dry Syrup + Placebo |
| WAL 801 CL Dry Syrup placebo | Drug | Ketotifen Fumarate Dry Syrup + Placebo |
| Ketotifen Fumarate Dry Syrup placebo | Drug | WAL 801 CL Dry Syrup + Placebo |
Primary outcome
Degree of pruritus
Time frame: at week 4
6 secondary outcomes
Degree of pruritus
Time frame: at week 2
Degree of rash
Time frame: at weeks 2 and 4
Pruritus score obtained through the itching questionnaire
Time frame: at weeks 2 and 4
Impression on pruritus of the patient or the parent
Time frame: at week 4
Occurrence of adverse events
Time frame: up to 4 weeks
Number of patients with abnormal changes from baseline in laboratory measurements (hematological tests, blood biochemical tests, and urinalysis)
Time frame: Baseline and week 4
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2014.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing WAL 801 CL Dry Syrup and Ketotifen Fumarate Dry Syrup in people with Dermatitis, Atopic, run by Boehringer Ingelheim.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Degree of pruritus (time frame: at week 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2014.